CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Liberty Cycler Cassettes (a disposable cassette recalled
Fresenius Medical Care Renal Therapies Group is recalling Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform, distributed nationwide in the US. The recall was initiated on 29 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2151-2019
- FDA event ID
- 83164
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2019
- FDA classified
- 5 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 29 May 2019 | Recall initiated by company | |
| 5 Aug 2019 | Classified by FDA | +68 days |
| 14 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
Which lots are affected?
All lots
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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